An Actual Use Study of Tamsulosin in Men with Bothersome Urinary Symptoms in a Simulated Over-the-Counter Setting

We assessed the ability of men with bothersome urinary symptoms to use an over-the-counter tamsulosin (0.4 mg) product concordant with the information in the proposed drug facts label in a simulated over-the-counter setting.

Eligibility for this 24-week study was determined by a phone interview. Men who reported not using (nonprescription users) or using (prescription users) a prescription medicine for benign prostatic hyperplasia at screening/baseline reviewed the proposed over-the-counter tamsulosin product. They could then choose to purchase this product and enter the actual use phase. The primary objective was to assess the proportion of nonprescription users compliant with "stop use" directions (performance threshold upper bound of 95% CI 10% or less). Secondary objectives included assessing the proportion of nonRx users compliant with other prespecified instructions on the proposed drug facts label and evaluating adverse events. Analyses were based on outcomes mitigated by a panel of urologists.

Of the 4,508 men screened 3,929 were eligible for product review and 1,117 entered the home use phase. Overall 1,074 men (nonprescription users 924, prescription users 150) purchased and used tamsulosin. Mean±SD age was 62.6±10.7 and 66.5±8.8 years, respectively. The primary end point was met, as only 2 of 924 nonprescription users (0.2%, 95% CI 0.0-0.8) reported a "stop use" condition within the first 12 weeks and did not appropriately stop use or initiate contact with a doctor. No unexpected safety concerns were observed.

Results indicate that self-directed use by men interested in using an over-the-counter tamsulosin product was in line with the drug facts label instructions implemented in this study and no unexpected safety concerns were identified.